DNA Test for Bladder Cancer Recurrence

The test has been cleared by the U.S. Food and Drug Administration (FDA) for monitoring recurrence of bladder cancer, and is the first genomic DNA test to be cleared for this purpose.

The test, from Vysis, Inc. (Downer's Grove, IL), is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from subjects with transitional cell carcinoma. Results from the test, called the UroVysion Kit, are intended for use as a noninvasive method for monitoring tumor recurrence in conjunction with cystoscopy in patients previously diagnosed with bladder cancer.

"We expect this ability to directly visualize genomic abnormalities in cells found in the patient's urine to represent a significant step in helping to improve the management of bladder cancer patients,” said John Bishop, president and CEO of Vysis.





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